A Phase 1-2 Study of PRT-201 Administered in Chronic Kidney Disease (CKD) Patients

PRT-201 is a protein that causes long lasting dilation of blood vessels when applied to the outside surface of the blood vessel. The purpose of this study is to determine if PRT-201, when applied to a limited segment of blood vessel immediately after surgery to create an arteriovenous fistula (AVF), is safe, dilates the blood vessel, and increases blood flow through the AVF.

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Key information

Conditions

Chronic Kidney Disease Arteriovenous Fistula Arteriovenous Malformations Cardiovascular Abnormalities Cardiovascular Diseases Chronic Disease Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Fistula Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Vascular Diseases Vascular Fistula Vascular Malformations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Clarian Health Partners/Indiana University/Purdue University, Indianapolis, Indiana, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age of at least 18 years.
Chronic kidney disease with anticipated start of hemodialysis within six months or current hemodialysis dependence.
Planned creation of a new AVF.

Exclusion criteria

Patients for whom this is the only potential site for an AVF.
By physical examination, absence of radial or ulnar artery flow or non-patent palmer arch.
Treatment with any investigational agent within the previous 30 days or investigational antibody therapy within 90 days of signing informed consent.
Pregnancy, lactation or plans to become pregnant during the course of the study.

Treatment and study plan

PRT-201

Drug

Applied topically to AVF during surgery

Primary outcomes

To assess the safety of a single topical dose of PRT-201. To assess the effect on the diameter of and blood flow through the AVF outflow vein.

Time frame: 2 & 6 weeks after AVF creation

Secondary outcomes

The proportion of patients with AVF patency, AVF maturation, and AVF use for hemodialysis.

Time frame: 3, 6, 9, and 12 months

Sponsors and collaborators

Lead sponsor

Proteon Therapeutics

Industry

Registry information

Official study title

A Phase 1-2, Multi-Center, Dose Escalation Study of a Single Dose of PRT-201 Administered Immediately After Arteriovenous Fistula Creation in Patients With Chronic Kidney Disease

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: May 19, 2008
Registry last updated: Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed